The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Location status: Recruiting
Location contact
Xiaojie Xia
CONTACT
86+87373012 ext. 025
Xiaolin Ge
PRINCIPAL_INVESTIGATOR
Xiaolin Ge, PHD
CONTACT
NCT Number: NCT06698692
Clinical data of patients with synchronous radiotherapy for esophageal cancer in the Department of Radiology of Jiangsu Provincial People's Hospital were collected. Patients were divided into trilaciclib group (34 cases) and control group (169 cases) based on whether trilaciclib was used or not. Patients in the trilaciclib group were given trilaciclib before each chemotherapy treatment. Propensity score matching (PSM) was used to balance the baseline characteristics between the two groups on a 1:1 ratio. After pairing, the rates of bone marrow suppression and other adverse events were compared between the two groups.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nanjing, Jiangsu, 210029, China
Location status: Recruiting
Xiaojie Xia
CONTACT
86+87373012 ext. 025
Xiaolin Ge
PRINCIPAL_INVESTIGATOR
Xiaolin Ge, PHD
CONTACT
chemoradiotherapy-induced myelosuppression (CIM) is the most common adverse event of concurrent chemoradiotherapy for esophageal cancer, often leading to reduction, delay or even cessation of chemotherapeutic agents. Clinical treatments for CIM mainly include various hematopoietic growth factors and blood transfusion. However, these interventions target only a single spectrum of blood cells and are susceptible to concomitant adverse events such as bone pain, thrombosis, and fever. Trilaciclib is a potent, transient, reversible CDK4/6 inhibitor and is the world's first innovative drug with lineage-wide myeloprotective effects. Its use in esophageal cancer has not been reported yet. In this study, we investigated the clinical efficacy and safety of trilaciclib in preventing myelosuppression in concurrent chemoradiotherapy for esophageal cancer for the first time.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Trilaciclib Combined chemoradiotherapy
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
Incidence of grade ≥3 neutropenia
Time frame: during Trilaciclib plus chemotherapy assessed up to 1 years
The incidence of Adverse Events according to Common Terminology Criteria for Adverse Events
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital with Nanjing Medical University
Other
Real-world Assessment of Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma
Acronym: COSELA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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